Description

Pazopanib Related Compound 2 is a high-purity chemical reference standard, identified by CAS number 1226500-02-2. This compound is essential for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) pazopanib hydrochloride during development and manufacturing. It serves as a critical impurity marker for pharmaceutical quality control laboratories and research institutions engaged in oncology drug development and analytical method validation.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference standard for the identification and quantification of specific impurities in pazopanib hydrochloride API and finished drug products.
• Analytical Method Development and Validation: Critical for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in compliance with ICH guidelines.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of degradation products in pazopanib formulations under various stress conditions.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and ensure drug safety.
• Quality Assurance/Quality Control (QA/QC): Serves as an in-house control standard for routine batch release testing of pazopanib-based medications.
• Research and Development: Used in synthetic chemistry research to study the metabolic pathways and degradation mechanisms of pazopanib.

Basic Information

Item	Detail
Product Name	Pazopanib Related Compound 2
CAS No.	1226500-02-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pazopanib Impurity 2; Pazopanib Related Substance 2; Pazopanib Hydrochloride Related Compound 2; 5-[[4-[(2,3-Dimethyl-2H-indazol-6-yl)methylamino]pyrimidin-2-yl]amino]-2-methylbenzenesulfonamide (Parent Pazopanib); Pazopanib Free Base; Votrient Impurity 2; GW786034 Related Compound 2
EINECS	Contact for details

Quality Control

Our Pazopanib Related Compound 2 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods and purity determination by HPLC. A Certificate of Analysis (COA) detailing batch-specific results is provided, supporting compliance with current Good Manufacturing Practice (cGMP) and ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.